Regulatory Affairs Specialist

3 days ago

Kottayam, Kerala, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000

We are seeking a highly skilled Regulatory Affairs Professional to manage regulatory documents and ensure compliance with international guidelines.

Responsibilities:
  • Coordinate with cross-functional teams to support product registrations, timely dossier submissions, and query responses.
  • Analyze documents received for product registration requests in accordance with country-specific regulations.
  • Prepare, compile, and review product dossiers to meet customer and regulatory requirements.
  • Develop and coordinate responses to regulatory queries with supporting documentation.
Requirements:
  • Graduate or postgraduate degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
  • Minimum 3-6 years of experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare.
  • In-depth understanding of global regulatory frameworks and dossier preparation best practices.
  • Excellent organizational and analytical skills, with attention to detail.
Favorable Skills:
  • Proficiency in MS Office (Word, Excel, PowerPoint) and document management systems.
  • Effective written and verbal communication skills.
  • Familiarity with international regulatory standards and guidelines.
About the Role:

This position involves working closely with internal teams to maintain regulatory compliance. The ideal candidate will have strong analytical and organizational skills, as well as excellent communication abilities.

The selected candidate will be responsible for coordinating product registrations, analyzing documents, preparing dossiers, and responding to regulatory queries. A solid understanding of global regulatory frameworks is essential for success in this role.

Additional responsibilities may include reviewing and revising existing processes to improve efficiency and effectiveness. Regular updates on industry developments and regulatory changes will also be required.

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